Gastrointestinal Tolerance of Formula Supplemented with Oligosaccharides

Objective Human milk oligosaccharides (HMOs) are the third largest solid component in mature human milk. The objective of this study was to evaluate gastrointestinal tolerance of infants fed infant formula supplemented with short‐chain fructooligosaccharides (scFOS) and 2‐fucosyllactose (2′FL). Methods We conducted a prospective, randomized, multi‐center, double‐blinded, controlled 3‐arm tolerance study in full term, singleton infants (birth weight ≥ 2490g) enrolled between 0 and 8 days of age. At enrollment, formula‐fed infants were randomized to one of two experimental milk‐based infant formulas with a caloric density of 643 kcal/L. Experimental Formula 1 (EF1) did not contain oligosaccharides (n=42) and Experimental Formula 2 (EF2) contained 2g/L scFOS and 0.2g/L 2′FL (n=46). The 2 formula groups were compared with a human milk‐fed (HM) reference group (n=43). Infants were exclusively fed formula or human milk from enrollment until 35 days of age. Data related to intake, stool patterns, anthropometrics and parental questionnaires were collected. The primary outcome was average mean rank stool consistency (MRSC) from Study Day 1 to Visit 3. MRSC was calculated from stool records (1=watery, 2=loose/mushy, 3=soft, 4=formed, 5=hard). Results Thirty‐six (86%) subjects in the EF1 group, 41 (89%) in the EF2 group and 42 (98%) in the HM group completed the study. There were no differences among groups for gender, ethnicity, race, gestational age, birth weight or age at enrollment. Reported results are from the protocol evaluable analysis. From Study Day 1 to Visit 3, there were no differences in MRSC among the three feeding groups. MRSC was 2.37 ± 0.10, 2.15 ± 0.10 and 2.06 ± 0.08 for the EF1, EF2 and HM groups respectively. There were also no differences among groups for predominant stool consistency from Study Day 1 to Visit 3. The average number of stools per day for the HM group was significantly greater than EF1 (p<0.0001) and EF2 (p<0.0001) from Study Day 1 to Visit 3. At Visit 3, there were no differences between groups for average volume of study formula intake, number of study formula feedings per day, anthropometric data or percent feedings with spit‐up/vomit. Conclusion An experimental formula containing 2′FL and scFOS was well tolerated in young infants as evidenced by stool consistency, formula intake, anthropometric data and percent feedings with spit‐up/vomit similar to that of infants fed formula without oligosaccharides or HM. Support or Funding Information This study was funded by Abbott Nutrition, Abbott Laboratories, Columbus, OH.